Determination of Regulatory Review Period for Purposes of Patent Extension; Vercise Genus Deep Brain Stimulation System, 54615-54617 [2023-17259]
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54615
Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
offers further understanding of current
programs and service populations,
explores options for program
improvement, and assesses alternative
policy and program designs. OPRE
anticipates undertaking a variety of new
research projects related to welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, family and
youth services, home visiting, child
welfare, trafficking, community
services, and other areas of interest to
ACF. Some ACF program offices
conduct their own research and
evaluation projects and may utilize this
generic.
Under this generic clearance, ACF
engages in a variety of formative data
collections with researchers,
practitioners, technical assistance
providers, service providers, and
potential participants throughout the
field to fulfill the following goals: (1)
inform the development of ACF
research, (2) maintain a research agenda
that is rigorous and relevant, (3) ensure
that research products are as current as
possible, and (4) inform the provision of
technical assistance and supports
around research and evaluation. ACF
envisions using a variety of techniques
including semi-structured discussions,
focus groups, surveys, and telephone or
in-person interviews, in order to reach
these goals. Information collected under
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inform ACF research activities and may
be incorporated into documents or
presentations that are made public.
The following are some examples of
ways in which we may share
information resulting from these data
collections: research design documents
or reports; research or technical
assistance plans; background materials
for technical workgroups; concept maps,
process maps, or conceptual
frameworks; contextualization of
research findings from a follow-up data
collection that has full PRA approval;
informational reports to TA providers;
or project specific reports, or other
documents relevant to the field, such as
federal leadership and staff, grantees,
local implementing agencies.
Following standard OMB
requirements, ACF has and will
continue to submit to OMB information
about individual information collection
activities proposed under the generic
clearance. ACF will provide OMB with
a copy of the individual instruments or
questionnaires, as well as other
materials describing the project. ACF
requests OMB’s review within 10 days
of submission of individual requests
under this generic.
Respondents: Respondents could
include key groups involved in ACF
projects and programs, state or local
government officials, service providers,
participants in ACF programs or similar
comparison groups, experts in fields
pertaining to ACF research and
programs, or others involved in
conducting ACF research or evaluation
projects.
Annual Burden Estimates
Find currently approved information
collections here: https://
www.reginfo.gov/public/do/PRAOMB
History?ombControlNumber=0970-0356.
The request to OMB will include an
extension request for approved
information collections that are planned
to continue beyond November 2023.
ANNUAL BURDEN ESTIMATES—NEW REQUESTS
Instrument
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
(total over
request
period)
Number of
respondents
(total over
request
period)
Average
burden per
response
(in hours)
Total burden
(in hours)
Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
3,000
1,500
1,125
1
1
1
2
1
.5
6,000
1,500
563
Total ..........................................................................................................
........................
........................
........................
8,063
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–17205 Filed 8–10–23; 8:45 am]
BILLING CODE 4184–79–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–1865]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Vercise Genus Deep Brain
Stimulation System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VERCISE GENUS DEEP BRAIN
STIMULATION SYSTEM (VERCISE
GENUS DBS SYSTEM) and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
SUMMARY:
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the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 10, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
February 7, 2024. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
ADDRESSES:
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Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 10, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
lotter on DSK11XQN23PROD with NOTICES1
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–E–1865 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; VERCISE GENUS
DBS SYSTEM.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device VERCISE GENUS DBS
SYSTEM. VERCISE GENUS DBS
SYSTEM is indicated for use in bilateral
stimulation of the subthalamic nucleus
(STN) as an adjunctive therapy in
reducing some of the symptoms of
moderate to advanced levodoparesponsive Parkinson’s disease (PD) that
are not adequately controlled with
medication. Subsequent to this
approval, the USPTO received a patent
term restoration application for
VERCISE GENUS DBS SYSTEM (U.S.
Patent No. 8,606,362) from Boston
Scientific Neuromodulation
Corporation, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated September
8, 2022, FDA advised the USPTO that
this medical device had undergone a
regulatory review period and that the
approval of VERCISE GENUS DBS
SYSTEM represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
I. Background
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VERCISE GENUS DBS SYSTEM
SYSTEM is 274 days. Of this time, 0
days occurred during the testing phase
of the regulatory review period, while
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
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Federal Register / Vol. 88, No. 154 / Friday, August 11, 2023 / Notices
274 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: Not Applicable. The applicant
claims no investigational device
exemption (IDE) for the regulatory
review period.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): April 23, 2020.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for VERCISE GENUS DBS
SYSTEM was initially submitted April
23, 2020.
3. The date the application was
approved: January 21, 2021. FDA has
verified the applicant’s claim that PMA
P150031 S034 was approved on January
21, 2021.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 273 days of patent
term extension.
lotter on DSK11XQN23PROD with NOTICES1
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
VerDate Sep<11>2014
16:59 Aug 10, 2023
Jkt 259001
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17259 Filed 8–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2853]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recordkeeping
and Reporting Requirements for
Human Food and Cosmetics
Manufactured From, Processed With,
or Otherwise Containing Material From
Cattle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of existing FDA
regulations concerning FDA-regulated
human food, including dietary
supplements, and cosmetics
manufactured from, processed with, or
otherwise containing material derived
from cattle.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 10, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 10, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
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54617
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–2853 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping and Reporting
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54615-54617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-E-1865]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Vercise Genus Deep Brain Stimulation System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for VERCISE GENUS DEEP BRAIN
STIMULATION SYSTEM (VERCISE GENUS DBS SYSTEM) and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that medical
device.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by October 10, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by February 7, 2024. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be
[[Page 54616]]
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
October 10, 2023. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-E-1865 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VERCISE GENUS DBS SYSTEM.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device VERCISE GENUS DBS
SYSTEM. VERCISE GENUS DBS SYSTEM is indicated for use in bilateral
stimulation of the subthalamic nucleus (STN) as an adjunctive therapy
in reducing some of the symptoms of moderate to advanced levodopa-
responsive Parkinson's disease (PD) that are not adequately controlled
with medication. Subsequent to this approval, the USPTO received a
patent term restoration application for VERCISE GENUS DBS SYSTEM (U.S.
Patent No. 8,606,362) from Boston Scientific Neuromodulation
Corporation, and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated September 8, 2022, FDA advised the USPTO that this medical device
had undergone a regulatory review period and that the approval of
VERCISE GENUS DBS SYSTEM represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
VERCISE GENUS DBS SYSTEM SYSTEM is 274 days. Of this time, 0 days
occurred during the testing phase of the regulatory review period,
while
[[Page 54617]]
274 days occurred during the approval phase. These periods of time were
derived from the following dates:
1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: Not Applicable. The applicant claims no
investigational device exemption (IDE) for the regulatory review
period.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): April
23, 2020. FDA has verified the applicant's claim that the premarket
approval application (PMA) for VERCISE GENUS DBS SYSTEM was initially
submitted April 23, 2020.
3. The date the application was approved: January 21, 2021. FDA has
verified the applicant's claim that PMA P150031 S034 was approved on
January 21, 2021.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 273 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17259 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
